myray ProXIma X6

K252353 · Cefla S.C. · OAS · Mar 10, 2026 · Radiology

Device Facts

• Record ID: K252353
• Device Name: myray ProXIma X6
• Applicant: Cefla S.C.
• Product Code: OAS · Radiology
• Decision Date: Mar 10, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ProXIma X6 is an extra-oral X-ray equipment for digital panoramic, tomographic and cephalometric X-rays exams, indicated for the following: (I) production of orthopanoramic images of the maxillofacial area, diagnostic dental exams on teeth, dental arches and other structures of the oral cavity; (II) Production of X-ray images of the dental arches, parts of the cranium and of the carpus in support of cephalometric examination, where the configuration includes the CEPH arm; (III) production of tomographic images of the structures of the maxillofacial area and oral cavity for diagnostic dental exams on teeth, dental arches, the structures of the oral cavity, where the configuration includes the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

Device Story

Extra-oral X-ray system for digital panoramic (2D), cephalometric (2D), and tomographic (CBCT, 3D) imaging; rotates around patient head using motorized arm on column support. Inputs: X-ray radiation through patient anatomy; constant-voltage generator; high-frequency power. Transforms inputs via X-ray detector and rotational sequence into 2D/3D images. Outputs: digital images transferred to PC for processing/viewing via 'Neowise' software. Used in dental clinics by physicians, dentists, or technologists. Healthcare providers use images for diagnostic dental exams of teeth, dental arches, maxillofacial structures, and cranium. Benefits: simplified, automated acquisition of dental images for diagnostic support.

Clinical Evidence

Bench testing only. Performance evaluated against predicate device using IEC 60601-1, IEC 60601-1-2, IEC 60601-2-63, and IEC 60825-1 standards. Image quality and radiation safety verified via comparative bench testing. Software validated per IEC 62304. Cybersecurity addressed per FDA guidance.

Technological Characteristics

Computed tomography X-ray system; 60-90 kV tube voltage; 2-16 mA current; fan-beam (2D) and cone-beam (3D) geometry. Detectors: CMOS/IGZO TFT with CsI scintillator. Connectivity: PC-based workstation. Software: Neowise. Mechanical: floor/wall-mounted column with motorized arm. Sterilization: N/A (extra-oral). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-63, IEC 60825-1, IEC 61223-3-7.

Indications for Use

Indicated for adult and pediatric patients requiring digital panoramic, tomographic, or cephalometric X-ray exams of the maxillofacial area, dental arches, teeth, cranium, and carpus for diagnostic dental purposes.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• hyperion X5 (K200688)

Reference Devices

• hyperion X9 Pro (K223794)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 10, 2026

Cefla S.C.
% Ilenia Muccione
Regulatory Affairs Manager
Via Selice Provinciale 23/A
IMOLA (Bo), BO 40026
ITALY

Re: K252353
Trade/Device Name: myray ProXIma X6
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: OAS, MUH
Dated: February 6, 2026
Received: February 9, 2026

Dear Ilenia Muccione:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252353 - Ilenia Muccione
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K252353 - Ilenia Muccione
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252353 | |
| Device Name myray ProXIma X6 | |
| Indications for Use (Describe) ProXIma X6 is an extra-oral X-ray equipment for digital panoramic, tomographic and cephalometric X-rays exams, indicated for the following: (I) production of orthopanoramic images of the maxillofacial area, diagnostic dental exams on teeth, dental arches and other structures of the oral cavity; (II) Production of X-ray images of the dental arches, parts of the cranium and of the carpus in support of cephalometric examination, where the configuration includes the CEPH arm; (III) production of tomographic images of the structures of the maxillofacial area and oral cavity for diagnostic dental exams on teeth, dental arches, the structures of the oral cavity, where the configuration includes the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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CEFLA S.C.
510(k) Premarket Notification

# K252353

# 510(k) SUMMARY, AS REQUIRED BY CFR 807.92

| Submitter's Name: | CEFLA S.C. |
| --- | --- |
| Address: | Via Selice Provinciale 23/a
Imola, BO 40026 ITALY
Tel. [phone]
Fax [phone] |
| Establishment Registration Number: | 3006610845 |
| Summary Preparation Date: | February 06th,2026 |
| Contact Person: | Ilenia Muccione, Regulatory Affairs |
| Telephone Number: | [phone] |
| Email: | [e-mail] |
| Trade/Device name: | myray ProXima X6 |
| Classification Name: | Computed Tomography X-Ray System
Classification Name: Computed Tomography X-Ray System
Device Class: II
Primary Product Code: OAS
Secondary Product Code: MUH
Regulation Number: 21 CFR §892.1750 |
| Description: | The ProXima X6 device, with its alternative proprietary names NewTom VG-One and EOS Compact is a panoramic (PAN, 2D), cephalometric (CEPH, 2D) and tomographic (CBCT, 3D) radiological system consisting of an X-ray system that acquires radiological images by rotating around the patient's head.
The X-ray device consists of a rotating arm fitted on a column support for carrying out panoramic X-rays or tomographic examinations.
The rotating arm is able to rotate and translate with motorized movements, allowing the X-ray generator and the image detector to move around the patient according to complex orbits that follow the morphological profile. The rotary arm is applied on a column support which can slide vertically through a motorized movement.
The X-ray device can feature a cephalometric examination arm, fitted on the column support. The arm houses a cephalostat, which keeps the patient position during the exam, and the image detector which translates in synchronization with the X-ray source movement.
User's choice, the X-ray device can be equipped with a single image detector (thus the operator must position it on the rotary arm for panoramic X-rays or on the cephalometric examination arm for tele-X-ray examinations - CEPH) or with two separate image detectors (which cannot be moved, one on the rotary arm and the other on the cephalometric examination arm).
The device is a digital imaging equipment created to simplify the acquisition process for X-ray image, intended for use by qualified professionals in the field, which allows to obtain dental images.
The image is acquired through the use of an X-ray detector and a constant-voltage X-ray source, powered by a high-frequency and high-voltage generator. The image is then transferred to a computer, either in real time (2D or 3D) or subsequently (2D) depending on the operator's selection and requirements. |

Page 1 of 13

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CEFLA S.C.
510(k) Premarket Notification

The device is operated and used by physicians, dentists, X-ray technologists and other legally qualified professionals.

ProXlma X6 is an extra-oral X-ray equipment for digital panoramic, tomographic and cephalometric X-rays exams, indicated for the following:

1. production of orthopanoramic images of the maxillofacial area, diagnostic dental exams on teeth, dental arches and other structures of the oral cavity;
2. Production of X-ray images of the dental arches, parts of the cranium and of the carpus in support of cephalometric examination, where the configuration includes the CEPH arm;
3. production of tomographic images of the structures of the maxillofacial area and oral cavity for diagnostic dental exams on teeth, dental arches, the structures of the oral cavity, where the configuration includes the CBCT option.

The equipment performs tomographic examinations through the acquisition of X-ray images through a rotational sequence and the reconstruction of a three-dimensional matrix of the volume examined, producing two- and three-dimensional views of this volume. This technique is known as CBCT.

ProXlma X6 is a digital X-ray unit, suitable for professionals in the sector, allowing them to obtain dental imaging in a simple, automated manner. The image is acquired through the use of an X-ray detector and a constant-voltage X-ray source, powered by a high-frequency high-voltage generator. The image is then transferred to a computer in real time for subsequent processing.

ProXlma X6 allows the following acquisitions to be made:

- paediatric panoramic or standard views (PAN);
- complete or partial view of the teeth, selected by the user (DENT);
- frontal and lateral views of the maxillary sinus (SIN);
- lateral and posterior-anterior views of the temporomandibular joints (TMJ).

Where equipped with CEPH arm, ProXlma X6 offers the following projections:

- cephalographies in latero-lateral view, in different formats;
- cephalographies in anteroposterior and posteroanterior view;
- hand (carpus) X-ray.

If the configuration includes CBCT exams, ProXlma X6 also allows the acquisition of tomographic images.

The device belongs to the category of panoramic, cephalometric and tomographic equipment, and does not present any new technology or innovation with respect to products currently marketed by the CEFLA and considered as predicate and reference devices.

ProXlma X6 predicate device is hyperion X5 already cleared by the Agency in K200688. Compared to the reference device Hyperion X9 Pro, ProXlma X6 is not able to perform otorhinolaryngologic analysis: particularly, sensor dimensions are not able to support images of the ear, nose and throat (ENT) area, and other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support.

ProXlma X6 apparatus consists of a rotary arm fitted on a column support for carrying out panoramic X-rays or tomographic examinations. The rotary arm features roto-translation motorized movements which allow moving X-ray emission system and image detector around the patient, according to complex orbits following the morphological profile. The rotary arm is applied on a column support which can slide vertically through a motorized movement.

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CEFLA S.C.
510(k) Premarket Notification

The configuration of ProXlma X6 device X-ray system consists of the main parts listed below:
1) Tomographic CBCT panel or Sensor for panoramic x-ray exams (alternatively)
2) Patient head support for panoramic and CBCT acquisitions
3) Arm for cephalometric x-ray exams (optional)
4) Sensor for cephalometric x-ray exams (optional)
5) Patient head support for cephalometric acquisitions (optional)
6) Handles for patient positioning
7) Laser pointers
8) X-ray source
9) Telescopic column (optional)
10) Stands for floor support (optional)

The device must be used in conjunction with software for acquisition and management of 2D and 3D images. The software system is identified for simplicity by the name 'Neowise,' which corresponds to the name of the interface module and appears on the user interface screens. The software is installed on a general purpose Personal Computer and offers all the functions necessary to perform the exam (from movements control to X-ray acquisition), save images and patient's data, manage, process, view and share 2D and 3D images, which can be obtained either from the CEFLA device or from external sources, and provides import/export of images or reports in different standard formats.

| Indication for Use: | ProXlma X6 is an extra-oral X-ray equipment for digital panoramic, tomographic and cephalometric X-rays exams, indicated for the following:
(I) production of orthopanoramic images of the maxillofacial area, diagnostic dental exams on teeth, dental arches and other structures of the oral cavity;
(II) Production of X-ray images of the dental arches, parts of the cranium and of the carpus in support of cephalometric examination, where the configuration includes the CEPH arm;
(III) production of tomographic images of the structures of the maxillofacial area and oral cavity for diagnostic dental exams on teeth, dental arches, the structures of the oral cavity, where the configuration includes the CBCT option.

The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. |
| --- | --- |
| Identification of Predicate Device: | CEFLA S.C. will refer to the following predicate device:
Proprietary Name: hyperion X5, NewTom GO, X-RADiUS COMPACT
Classification Name: Computed tomography x-ray system, 21 CFR 892.1750
Product Code: OAS, MUH
Applicant/Manufacturer: Cefla S.C.
Via Selice Provinciale 23/c
40026 Imola (BO) - Italy
510 (k): K200688 |
| Identification of Reference Device: | CEFLA S.C. will refer to the following reference device:
Proprietary Name: hyperion X9 Pro
Classification Name: Computed tomography x-ray system, 21 CFR 892.1750
Product Code: OAS, MUH
Applicant/Manufacturer: CEFLA S.C.
Via Selice Provinciale 23/c
40026 Imola (BO) - Italy
510 (k): K223794 |

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CEFLA S.C.

510(k) Premarket Notification

| Comparison of technological characteristics with the predicate and reference devices: | Characteristic | Proposed Device | Predicate Device | Reference Device |
| --- | --- | --- | --- | --- |
| | Device Name | ProXima X6 | hyperion X5, NewTom GO, X-RADiUS COMPACT | hyperion X9 pro |
| | Manufacturer | CEFLA S.C | CEFLA S.C. | CEFLA S.C. |
| | 510(K) No. | - | K200688 | K223794 |
| | Regulation Number | 892.1750 | 892.1750 | 892.1750 |
| | Regulation Name | Computed tomography x-ray system | Computed tomography x-ray system | Computed tomography x-ray system |
| | Regulatory Class | Class II | Class II | Class II |
| | Classification Product Code | OAS
(Classification Product Code)
MUH
(Subsequent Product code) | OAS
(Classification Product Code)
MUH
(Subsequent Product code) | OAS
(Classification Product Code)
MUH
(Subsequent Product code) |
| | Indication for use | ProXima X6 is an extra-oral X-ray equipment for digital panoramic, tomographic and cephalometric X-rays exams, indicated for the following:
(I) production of orthopanoramic images of the maxillofacial area, diagnostic dental exams on teeth, dental arches and other structures of the oral cavity;
(II) Production of X-ray images of the dental arches, parts of the cranium and of the carpus in support of cephalometric examination, where the configuration includes the CEPH arm;
(III) production of tomographic images of the structures of the maxillofacial area and oral cavity for diagnostic dental exams on teeth, dental arches, the structures of the oral cavity, | The hyperion X5 is a digital extra-oral X-ray system for panoramic, cephalometric and tomographic images, intended to:
(I) produce ortho-panoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;
(II) produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH);
(III) produce tomographic images of the oral and maxillofacial cavities structures, for the diagnostic examination of the dentition (teeth) | hyperion X9 pro is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to:
(I) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;
(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH); |

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CEFLA S.C.
510(k) Premarket Notification

| | where the configuration includes the CBCT option.

The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | arches, structures of the oral cavity and of some skull bones. if equipped with CBCT option.

The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | (III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillo-facial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMJ), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option.

The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. |
| --- | --- | --- | --- |
| Performance features | | | |
| Performance specification | Panoramic
Computed tomography
Cephalometric | Panoramic
Computed tomography
Cephalometric | Panoramic
Computed tomography
Cephalometric |
| Patient population | Adult
Paediatric | Adult
Paediatric | Adult
Paediatric |
| Exposition selectable | 2D: PAN, DENT, SIN, TMJ, PAN BITEWING, CEPH
3D: Computed Tomography (CBCT) | 2D: PAN, DENT, SIN, TMJ, PAN BITEWING, CEPH
3D: Computed Tomography (CBCT) | 2D: PAN, BTW (bitewing), DENT, SIN, TMJ, CEPH
3D: Computed Tomography (CBCT) |
| Technical & Functional features comparison: (A) X-Ray emission | | | |
| Tube voltage | 60-90 kV | Panoramic (PAN) and Cephalometric (CEPH) exams: 60 - 85 kV - continuous emission | Panoramic (PAN) and Cephalometric (CEPH) |

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CEFLA S.C.
510(k) Premarket Notification

| | | Panoramic (PAN) and Cephalometric (CEPH): the voltage is continuous.
CBCT: The voltage is pulsed with a predetermined duty cycle for tomographic acquisitions. | CBCT: 90 kV pulsed mode | exams: 60 - 85 kV - continuous emission
CBCT: 90 kV pulsed mode |
| --- | --- | --- | --- | --- |
| | Tube current range | 2D: 4 - 15 mA
2D/3D: 2 - 16 mA | 4 – 15 mA | 2 - 16 mA |
| | Exposure Time range | 2D mode: 1 s – 15 s continuous radiation
3D mode (only 2D/3D models): 1 s – 40 s pulsed mode | Panoramic: 1s–15s continuous radiation
CBCT: 1s – 10 s pulsed mode | 2D: 1s- 18s continuous emission
CBCT: 1s -10.4 s pulsed emission |
| | Shape of X-Ray Beam | PAN: Fan-shaped beam
CEPH: Fan-shaped beam
CBCT: cone beam | PAN: Fan-shaped beam
CEPH: Fan-shaped beam
CBCT: cone beam | PAN and CEPH: fan-shaped beam
CBCT: cone beam |
| | Focal Spot | For 2D models: 0.5, 0.6 mm
For 2D/3D models: 0.6 mm | PAN, CEPH: 0.5, 0.6 mm
CBCT: 0.6 mm | PAN, CEPH and CBCT: 0.5mm |
| | Collimator | One standard primary collimator of fixed beam type, with a single field of irradiation of the x-ray beam for panoramic x-ray configurations.
One primary collimator, adjustable in function of selected projection for 3D / 2D imaging configurations.
One secondary collimator for CEPH. | One primary collimator, adjustable in function of selected projection.
One secondary collimator for CEPH. | One primary collimator, adjustable in function of selected projection.
One secondary collimator for CEPH.
Correspondence between X-ray field and effective image reception area
According to IEC 60601-2-63. |
| | FOV | Max 15x11
Min: 5x4 | Max 10x10
Min: 6x6 | Max: 16x18 cm
min: 4x4 cm |
| | Technical & Functional features comparison: (B) SSD Detector & IMAGE acquisition | | | |
| | Image Detector Technology | Panoramic (PAN) and Cephalometric (CEPH) exams: CMOS or IGZO TFT
CBCT: Amorphous Silicon or IGZO TFT | Panoramic (PAN) and Cephalometric (CEPH) exams: CMOS detector
CBCT: Amorphous Silicon | 2D X-ray imaging: |

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CEFLA S.C.
510(k) Premarket Notification

| | | Only for devices equipped with the CEPH arm option, PAN and CEPH Image detectors are interchangeable. | PAN and CEPH Image detectors are interchangeable. | 1) CMOS detector with scintillator Direct Deposition CSI; 2) Direct conversion CMOS detector. 3D Image X-ray sensor CBCT: Amorphous Silicon Flat Panel. |
| --- | --- | --- | --- | --- |
| | Sensor module 2D | CMOS detector (PAN/CEPH) 1501(S)/2301(S) CMOS detector (PAN/CEPH) 2304 | CMOS detector (PAN/CEPH) C10500D-70/C10502D-70 | CMOS detector (PAN/CEPH) C10500D-70/C10502D-70 CMOS detector (PAN/CEPH) 1501S GigE / 2301S GigE CMOS detector (PAN/CEPH) UFS-150-44 / UFS-225-44 |
| | Sensor module 2D / 3D | IGZO detector EXPD (CBCT) 1616P IGZO detector (CBCT) 1616Z | Amorphous Silicon (CBCT) 1616DXT | Amorphous Silicon Flat Panel (CBCT) 1616DXT |
| | Image detectors dimension | PAN: | PAN: CMOS detector C10500D-70 6 x 148 mm | PAN: CMOS detector C10500D-70 6 x 148 mm |

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CEFLA S.C.
510(k) Premarket Notification

| | | CMOS detector1501(S)
6.7 x 152 mm

CMOS detector 1536
6.2 x 149 mm

CEPH:

CMOS detector2301(S)
6.7 x 228 mm

CMOS detector 2304
6.2 x 223 mm

CBCT:

IGZO detector EXPD 1616P
159.544x159.544mm

IGZO detector 1616Z
161.3x161.3mm | CEPH:
CMOS detector
C10502D-70 6 x 223 mm

CBCT:

Amorphous Silicon 1616DXT
162.56x162.56mm | CMOS detector 1501S GigE
6.7 x 152 mm

CMOS detector UFS-150-44
4,4 x 153,6 mm

CEPH:

CMOS detector C10502D- 70
6 x 223 mm

CMOS detector 2301(S)
6.7 x 228 mm

CMOS detector UFS-225-44
4,4 x 230,4 mm

CBCT:

Amorphous Silicon Flat Panel 1616DXT
162 x 162 mm |
| --- | --- | --- | --- | --- |

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CEFLA S.C.
510(k) Premarket Notification

| | Detector Pixel size | CMOS detector (PAN/CEPH) 1501(S) / 2301(S): 99 μm
CMOS detector (PAN/CEPH) 1536 / 2304: 97 μm
IGZO detector EXPD (CBCT) 1616P: 98 μm
IGZO detector (CBCT) 1616Z: 105 μm | CMOS detector (PAN/CEPH) C10500D-70 / C10502D-70: 100 μm
Amorphous Silicon (CBCT) 1616DXT: 127 μm | CMOS detector (PAN/CEPH) C10500D-70 / C10502D-70: 100 μm
CMOS detector (PAN/CEPH) 1501S GigE / 2301S GigE: 99 μm
CMOS detector (PAN/CEPH) UFS-150-44 / UFS- 225-44: 100 μm
Amorphous Silicon Flat Panel (CBCT) 1616DXT: 127 μm |
| --- | --- | --- | --- | --- |
| | CBCT Conversion Screen (scintillator) | CsI | CsI | CsI |
| | PAN (CEPH) Conversion Screen (scintillator) | CsI | CsI | CsI |
| | Modulation transfer function (MTF) | ≥57% @ 1 lp/mm (1x1) | 57% @ 1 lp/mm (1x1) | >48% @ 1 lp/mm (1x1 mode) |
| | Detective quantum efficiency (DQE) | PAN: | 70% @ 0 lp/mm (1x1) | |

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| | | CMOS detector 1501(S): 70% @ 0 lp/mm (1x1)
CMOS detector 1536: 70% @ 0 lp/mm (1x1)
CEPH:
CMOS detector 2301(S): 70% @ 0 lp/mm (1x1)
CMOS detector 2304: 70% @ 0 lp/mm (1x1)
CBCT:
IGZO detector EXPD 1616P: 65% @ 0 lp/mm (1x1)
IGZO detector 1616Z: 78% @ 0 lp/mm (1x1) | | 70% @ 0 lp/mm (1x1) |
| --- | --- | --- | --- | --- |
| | Source to image detector distance (SID) | 2D PAN: 500 mm
2D CEPH: 1610 mm
3D CBCT: 500 mm | PAN: 500 mm
CEPH: 1610 mm
CBCT: 500 mm | PAN: 550 mm ± 5 mm
CEPH: 1554 mm ± 8 mm
CBCT: 650 mm ± 5 mm |
| --- | --- | --- | --- | --- |
| | Acquisition path | 3 axis - CBCT scan: 210° | 2 axis – CBCT scan: 210° | 2 axis – CBCT scan: 210° |
| | Technical & Functional features comparison: (C) Laser & positioning | | | |
| | Number of laser pointer | 5 (3 on the monoblock, 2 on the patient arm) | 3 | 6 (adjustable) |
| | Laser optical class | Class 1 for IEC 60825-1 | Class 1 for IEC 60825-1 | Class 1 according to IEC 60825-1 |
| | Number of point of cephalostat | 2 (adjustable) | 3 (adjustable) | 3 (adjustable) |
| | Technical & Functional features comparison: (D) Control & Viewing Software | | | |

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| Control SW | Firmware
(two possible configurations:
1. software on a general-PC (Windows PC) which is external to the device (Workstation);
2. two computers, an on-board machine (Acquisition Board) and an external computer (Workstation). | Firmware + VKB
(on PC or Tablet) | Firmware (on board) + VKB |
| --- | --- | --- | --- |
| Viewing & reconstruction software | Neowise | NNT / iRYS | NNT / iRYS |
| Software validation | IEC62304
+ Guidance FDA on MD SW | IEC62304
+ Guidance FDA on MD SW | IEC62304
+ Guidance FDA on MD SW |
| Technical & Functional features comparison: (E) Mechanical configurations | | | |
| Wall installation
Suspended | Yes | Yes | Yes |
| | Floor version with column | Yes | Yes | Yes |
| --- | --- | --- | --- | --- |
| | Floor version with column and standard base | Yes | Yes | Yes |

**Non-clinical Performance Testing:**

Electrical safety Test was conducted and performed in accordance with IEC 60601-1.

Electromagnetical Compatibility test was conducted and performed in compliance with IEC 60601-1-2.

Furthermore, the proposed device has been tested in compliance with the standards IEC 60601-2-63 and IEC 60825-1.

The software has been developed and validated according to IEC 62304.

Performance tests have been performed in comparison with predicate device to demonstrate that the image quality and the radiation safety of the proposed device can be considered equivalent.

Bench testing was conducted for all newly introduced detectors per FDA guidance document, Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices.

Bench testing conducted was performed in accordance with IEC 61223-3-7.

Cybersecurity requirements were addressed per FDA guidance document, Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions.

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Clinical
Testing:

The clinical evaluation was conducted for all claimed imaging modes, as summarized in the table below. The table also identifies the detectors available for each device configuration, taking into account the specific imaging modes performed. Supporting evidence has been provided to demonstrate that the detector used in the clinical evaluation is representative of the subject device configurations with respect to image quality.

| ProXima X6-2D | |
| --- | --- |
| Panoramic Exams (2D): • PAN ADULT • PAN CHILD • BTW - BITEWING • DENT (complete or partial views) • SIN (FRONT, L,R) • TMJ (front lat both) | Cephalometric Exams (2D): • PAN ADULT • PAN CHILD • BTW - BITEWING • DENT (complete or partial views) • SIN (FRONT, L,R) • TMJ (front lat both) |
| DETECTORS | |
| CMOS detector 1501(S) CMOS detector 1536 CMOS detector 2301(S) CMOS detector 2304 | CMOS detector 2301(S) CMOS detector 2304 |
| ProXima X6-3D | | |
| --- | --- | --- |
| Panoramic Exams (2D): • PAN ADULT • PAN CHILD • BTW - BITEWING • DENT (complete or partial views) • SIN (FRONT, L,R) • TMJ (front lat both) | Cephalometric Exams (2D): • PAN ADULT • PAN CHILD • BTW - BITEWING • DENT (complete or partial views) • SIN (FRONT, L,R) • TMJ (front lat both) | Tomographic CBCT Exams (3D): • DENT 3D • SIN 3D • TMJ 3D |
| DETECTORS | | |
| IGZO detector EXPD 1616P (panmode) IGZO detector 1616Z (panmode) | CMOS detector 2301(S) CMOS detector 2304 | IGZO detector EXPD 1616P IGZO detector 1616Z |

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Conclusion:
CEFLA S.C. considers the ProXlma X6 (and all other different brand names) to be substantially equivalent to the predicate device. This conclusion is based on the similarities in intended use, principle of operation, functional design, and established medical use. Differences between the devices shown in the comparison section above are minor and do not have any negative effect on substantial equivalence.

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